Sabin脊髓灰质炎灭活疫苗病毒纯化层析柱柱效的建立

Establishment and Evaluation of Chromatographic Columns to Purify Sabin Inactivated Poliomyelitis Vaccine

目的:建立Sabin株脊髓灰质炎灭活疫苗(Vero细胞)病毒浓缩液(s IPV)纯化层析柱柱效。方法:连续对3个批次Sabin s IPV病毒的纯化工艺的凝胶层析柱和离子层析柱的柱效进行检测并分析其柱效值,检测两种层析获得的病毒纯化液的D抗原、总蛋白含量、比活性及纯度。结果:通过对连续3个批次的s IPV病毒纯化工艺的监测,建立凝胶层析柱的柱效不低于3 605 N/m,离子层析柱的柱效不低于2 222 N/m,凝胶柱效值>离子柱的柱效值,连续3批检测D抗原和总蛋白含量稳定,比活性为78～86 DU/μg,纯度为100%。结论:建立的层析柱柱效获得的病毒纯化液质量稳定。

Objective:To establish chromatographic columns to purify Sabin inactivated Poliomyelitis Vaccine(sIPV)and evaluate their purification efficiency.Methods:sIPV was first purified through gel chromatography column and then through ion chromatography column.We examined purification efficiencies of three consecutive batches of purified siPV.The D antigens,total protein content and specific activity were detected after purification.Results:The efficiency of the gel chromatography column was not less than 3 605 N/m and the efficiency of the ion chromatography column was not less than 2 222 N/m.The efficiency of the gel column is great than the efficiency of the ion column.In addition,the D antigens and the total protein content were stable in these three batches,and the specific activity was 78~86 DU/μg,and the purity was 100%.Conclusion:The quality of the purified vaccine solution obtained by chromatographic column is stable.